Medication info

Empagliflozin/Metformin Tablet 5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Brownish-yellow, biconvex, oval film-coated tablet
Packaging
10 tablets/box [(10 tablets/PTP×1)], 60 tablets/box [(10 tablets/PTP×6)], 60 tablets/bottle
Approval status
Active

MFDS item code 202201366 · Approved 2022.04.04

Summary

Main use
Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage for this medication is 1 tablet, 2 times a day. The dosage for each ingredient should not exceed the maximum recommended daily dosage of 25 mg of empagliflozin and 2000 mg of metformin, determined considering each patient's current treatment regimen, effectiveness, and tolerability. - For patients unable to achieve adequate blood sugar control with monotherapy using metformin or in combination with other medications such as insulin, the recommended dosage is 5 mg of empagliflozin, administered twice daily (total daily dose 10 mg).

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes in adults
  • abnormal blood sugar control
  • cardiovascular diseases
View approved original text

This medication is used to improve blood sugar control in adults with type 2 diabetes, in conjunction with diet and exercise. It is particularly suitable for patients whose blood sugar is not adequately controlled and can also assist in the treatment of patients with concurrent cardiovascular diseases. This medication enhances blood sugar control through the combination of empagliflozin and metformin, improving overall diabetes management. However, considerations related to cardiovascular diseases must be carefully noted as specified in the precautions for use. Such treatment effectively improves patients' blood sugar control.

How to take

Adult dose

The recommended dosage for this medication is 1 tablet, 2 times a day. The dosage for each ingredient should not exceed the maximum recommended daily dosage of 25 mg of empagliflozin and 2000 mg of metformin, determined considering each patient's current treatment regimen, effectiveness, and tolerability. - For patients unable to achieve adequate blood sugar control with monotherapy using metformin or in combination with other medications such as insulin, the recommended dosage is 5 mg of empagliflozin, administered twice daily (total daily dose 10 mg).

Precautions

This medication helps with blood sugar control and is used in diabetes treatment. It can cause a rare side effect called severe lactic acidosis, so patients with poor kidney function or liver problems should not take it. Additionally, caution is required as hypoglycemia may occur when taken with insulin or sulfonylurea medications. Patients with moderate to severe kidney impairment, acute infections, dehydration, heart failure, or acute myocardial infarction should not take this medication. It is necessary to temporarily discontinue this medication before and after diagnostic tests using iodine contrast agents, resuming only after kidney function is confirmed to be normal. Pregnant or breastfeeding women should not take this medication, and it is also not recommended for children under 18 years of age. While taking this medication, side effects may occur, including symptoms of hypoglycemia, urinary infections, genital infections, increased urination, gastrointestinal disturbances; if symptoms appear, patients should inform healthcare professionals immediately. Especially, elderly patients or those at risk of decreased fluid volume should be cautious of dehydration and hypotension and should have regular kidney function tests. There may also be interactions with other medications taken alongside; if other medications are being used, it is essential to inform healthcare professionals. In the event of overdose, serious side effects such as lactic acidosis may occur, and patients should visit a healthcare facility immediately; treatment may require dialysis. This medication should be kept out of reach of children and stored in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • lactic acidosis
  • ketoacidosis
  • angioedema
  • perineal necrosis
  • pneumonia
  • urosepsis
  • pyelonephritis
  • liver abnormalities (jaundice)
Show 18 more
  • hepatitis
  • myocardial infarction
  • cerebral infarction
  • intracranial aneurysm
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • severe skin reactions
  • severe allergic reactions
  • difficulty breathing
  • asthma attacks
  • chest tightness
  • cold sweat
  • pallor
  • significantly reduced urine output
  • elevated blood pressure
  • acute

Mild side effects

  • Hypoglycemia
  • urinary tract infection
  • genital infection
  • increased urination
  • nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • loss of appetite
  • constipation
Show 21 more
  • abnormal liver function tests
  • hepatitis
  • altered taste
  • itching
  • rash
  • increased serum lipids
  • increased blood creatinine
  • difficulty urinating
  • abnormal test results
  • decreased and deficiency of vitamin B12
  • decrease in fluid volume
  • dizziness
  • headache
  • weakness
  • chest discomfort
  • chest pain
  • fever
  • insomnia
  • weight loss
  • vulvar pruritus
  • cough

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The best storage temperature is room temperature between 1 degree and 30 degrees Celsius, to maintain the medication's effectiveness.

Appearance and packaging

Appearance

Brownish-yellow, biconvex, oval film-coated tablet

Package unit

10 tablets/box [(10 tablets/PTP×1)], 60 tablets/box [(10 tablets/PTP×6)], 60 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.